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Overview

Disclosure and transparency of clinical trial information is taking on new dimensions, resulting in trial sponsors and research organisations facing a host of new requirements in the EU, US, and other places in the world. This 2018 Conference builds on prior conference discussions and leverages learnings from International experts, providing the opportunity to gain insights on how to meet the new challenges and opportunities. The program is assembled around key themes:

  • Upcoming implementation of the EU Clinical Trial Regulation: Portal and Database Status/Updates
  • Operational tools and strategies sponsors are using to comply with EMAs Clinical Data Publication Policy 0070
  • Best practices in meeting the expanded requirements of the NIH Final Rule for FDAAA (42 CFR Part 11)
  • Legal requirements related to disclosure of clinical research information for medicinal products and medical devices
  • How the new ICMJE data sharing requirements are being implemented
  • Impact of the EU General Data Protection Regulation (GDPR) on data sharing
  • Approaches to navigating and complying with global disclosure and transparency requirements

Attendees will learn from case studies and the experiences of experts and their peers.

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What you will learn

Developments in relation to implementation of EMAs Clinical Data Publication Policy 0070, NIH Final Rule for FDAAA, ICMJE Data Sharing Requirement, EU GDPR, EU Medical Device Regulation, Health Canada’s draft guidance on Public Release of Clinical Information, and FDAs new initiatives on sharing clinical documents publicly:

  • Latest updates from EMA and NIH (on ClinicalTrials.gov)
  • Best practices for operationalizing EMA’s Clinical Data Publication Policy 0070 submissions including risk assessments
  • Compare and contrast qualitative and quantitative data anonymisation techniques for sharing of individual participant data
  • Utility of redacted/anonymized clinical data
  • Planning for submissions to ClinicalTrials.gov
  • Planning and thinking ahead for submission of documents for EMAs Clinical Data Publications Policy 0070 and documents for inclusion of results submission for ClinicalTrials.gov
  • Understand the legal impact of the EU General Data Protection Regulation (GDPR) on data sharing
  • Clinical trial disclosure and transparency requirements in the upcoming EU Medical Device Regulation
  • Compare and contrast EMA, FDA and Health Canada’s clinical data publication policies
  • Operationalizing ICMJE’s new data sharing statement requirement – How Sponsors are Approaching this new requirement/Experience to date from the ICMJE
  • Experiences with FDA’s Pilot Clinical Data Publication Project
  • Strategies for preparing for implementation of the EU Clinical Trials Regulation
  • Company strategies regarding returning trial results to participants and meeting the EU
  • Clinical Trial Regulation requirements for trial results summaries for laypersons

Who should attend?

  • Professionals and experts from areas affected by public disclosure across drug and medical device development (regulatory affairs, scientific affairs, medical writing, clinical operations, medical communication, biostatisticians/biometrics, project management, medical affairs, legal, patent departments, etc.)
  • Consultants, CROs and companies that offer services for clinical registries, publication planning and medical writing
  • Patient organisations
  • Regulatory agencies
  • Academic institutions

Learning objectives

  • Learn about the latest developments relating to the implementation of the EMA Clinical Data Publication Policy 0070, FDAAA Final Rule, ICMJE Data Sharing Statement Requirement, EU GDPR, Health Canada’s new clinical publication regulation and EU MDR from regulators, legal experts as well as industry experts
  • Benefit from the various perspectives on regulatory, legal aspects and practical challenges from large, mid-sized, and smaller sponsor organisations
  • Leverage best practices on the practical implementation through case studies by the exchanging of views between regulators, industry, patients, academia and other stakeholders
  • Use of the option for networking and asking questions to your own specific situation and area of responsibility

Program Committee

  • Virginia Lee Acha, PhD, MSc
    Virginia Lee Acha, PhD, MSc Executive Director, Global Regulatory Policy
    MSD, United Kingdom
  • Merete  Joergensen, MBA, MSc
    Merete Joergensen, MBA, MSc Senior Trial Disclosure Director, Global Clinical Registry
    Novo Nordisk A/S, Denmark
  • Robert  Paarlberg, MS
    Robert Paarlberg, MS Principal
    Paarlberg & Associates LLC, United States
  • Rebecca J. Williams
    Rebecca J. Williams Assistant Director, ClinicalTrials.gov, NCBI
    National Institutes of Health (NIH), United States
  • Matthias  Zerm, PhD
    Matthias Zerm, PhD Lead Expert, Clinical Trial Disclosure and R&D Processes
    Merz Pharmaceuticals GmbH, Germany
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Digital Learning Catalog

DIA Learning: 2018 eLearning Soultions
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